Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)

Summary

Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.

Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.

Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.

Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.

Conditions

• Laparotomy

Interventions

DRUG

Oxygen

During and 2 hours after surgery

Sponsors & Collaborators

• The Danish Medical Research Council

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Lars S. Rasmussen, MD,DMSc,PHD · Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

• Jørn Wetterslev, MD, PHD · Copenhagen Trial Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

• Lars N. Jørgensen, MD, DMSc · Dept. of Surgery, Copenhagen University Hospital, Bispebjerg, Copenhagen, Denmark

• Christian S. Meyhoff, MD, PhD · Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2008-10-31

Completion

2008-11-30

Countries

• Denmark

Study Locations